Comparison of the Q-NRG+ Indirect Calorimetry Device Versus the V(Max) Encore Device in Mechanically Ventilated Children

NCT04482556 | Unknown FDA Device

• 1 other identifier: IRB-P00033440
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The overarching aim of this proposal is to examine the feasibility of the Q-NRG+ indirect calorimetry device and its agreement with (Vmax) Encore indirect calorimetry device in mechanically ventilated children. The overall hypothesis of this study is that the Q-NRG+ will provide minute-to-minute oxygen consumption (VO2) and carbon dioxide production (CO2) measurements that are in agreement with those obtained by the standard indirect calorimetry device currently used at our institution (Vmax Encore).

Conditions

Calorimetry, Indirect; Oxygen Consumption; Metabolism; Mechanical Ventilation

Keywords

Pediatrics; Indirect Calorimetry; Enteral Nutrition; Metabolism; Critical Care

Outcome Measures

Primary Outcomes (2)

• Mean bias and limits of agreement between measured oxygen consumption (VO2) and carbon dioxide elimination (VCO2) in mechanically ventilated children assessed using the Q-NRG+ indirect calorimetry device and the V(max) Encore indirect calorimetry device.

  In mechanically ventilated children, we will describe the mean bias and limits of agreement in measurements using both indirect calorimeters. Our hypothesis is that the measurement of oxygen consumption (VO2) and carbon dioxide production (VCO2) with the 2 devices will have a low mean bias and will be within clinically acceptable limits of agreement.

  1 hour/participant

• Calculated total testing time, including calibration, required to complete a steady state indirect calorimetry measurement using the Q-NRG+ device and the V(max) Encore.

  Total time lapsed, including time for patient data input, warm-up, calibration, and gas exchange measurements in steady state will be recorded. Our hypothesis is that the time required to obtain energy expenditure with Q-NRG+ device will be significantly shorter as compared to the Vmax Encore device.

  1 hour/participant

Study Arms (2)

Q-NRG+ Indirect Calorimetry Device

OTHER

Q-NRG+ device will be compared to current V(max) device in each enrolled patient in subsequent, alternating fashion.

Device: Q-NRG+ Indirect Calorimetry Device

V(max) Encore Indirect Calorimetry Device

OTHER

V(max) Encore device, currently institution's standard device, will be compared to Q-NRG+ device in each enrolled patient in subsequent, alternating fashion.

Device: V(max) Encore Indirect Calorimetry Device

Interventions

Q-NRG+ Indirect Calorimetry Device DEVICE

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

Q-NRG+ Indirect Calorimetry Device

V(max) Encore Indirect Calorimetry Device DEVICE

The two indirect calorimetry devices will be tested in an alternating fashion for each enrolled patient. Each enrolled patient subsequently will alternate in which device is tested first.

V(max) Encore Indirect Calorimetry Device

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children mechanically ventilated with endotracheal tube of tracheostomy in standard ventilatory modes such as SIMV-PC, SIMV-VC or PRVC
• Age \> 10 years AND weight \> 10kg
• FIO2 \< 60%
• PEEP \< 8
• ETT leak \< 10%
• The attending physician of record plans to order indirect calorimetry and considers research activity safe

You may not qualify if:

• Hemodynamic instability (hypotension according to PALS/ACLS formula or requiring 2 or greater vasoactive infusions)
• Presence of chest tubes with ongoing air leak
• Patients requiring ECMO support
• Patients undergoing end-of-life care
• Primary provider declines enrollment.

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Study Officials

• Nilesh M Mehta, MD

  Boston Children's Hospital

  STUDY DIRECTOR

Central Study Contacts

Ben D Albert, MD

CONTACT

617-355-7327; ben.albert@childrens.harvard.edu

Nilesh M Mehta, MD

CONTACT

617-355-7327; Nilesh.Mehta@childrens.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Critical Care Medicine Fellowship Program

Study Record Dates

• First Submitted: July 17, 2020
• First Posted: July 22, 2020
• Study Start: January 1, 2020
• Primary Completion: December 1, 2024
• Study Completion: December 31, 2024
• Last Updated: January 3, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)